Agenda - Day Two: Friday, September 5 | PCC West | Pharmaceutical Compliance Congress

8:15am - 8:45am

Continental Breakfast & Networking

8:45am - 9:00am

Chair’s Day Two Opening Remarks

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HCP Engagement & Communication

9:00am - 9:45am

Interpretation and Implementation of FDA’s Updated Guidance on Scientific Information on Unapproved Uses (SIUU)

Hear an overview of the updated SIUU guidance and analysis of the differences between the former draft guidance and final guidance
Explore areas of the guidance subject to interpretation and best practices in interpreting these areas to minimize risk
Examine how to implement and operationalize the final guidance to optimize risk

Kari Loeser - Vice President & Chief Compliance Officer, Cytokinetics
Achsah Warren, MSJ - Vice President, Head of Compliance, Sumitomo Pharma America, Inc.

9:45am - 10:30am

Managing New Field-Facing Role Types – How to Mitigate Risk and Establish Guardrails

Discuss how to define precise scopes of work for emerging field-facing roles (e.g., thought leader liaisons, reimbursement managers), explicitly outlining permissible and prohibited activities
Learn how to establish clear lines of demarcation between promotional and non-promotional activities to prevent inadvertent off-label promotion or other compliance violations
Explore strategies to implement monitoring and auditing procedures to detect and address potential compliance violations, including reviews of field activity reports and interactions with HCPs and patients

Stefanie Doebler - Partner, Covington and Burling LLP
Peter Lee - Vice President, Chief Compliance Officer, Kura Oncology
Sharon Delshad - Director, Legal Affairs, Corporate and Compliance Counsel, Travere Therapeutics

10:30am - 11:00am

Networking & Refreshment Break

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HCP Engagement & Communication

11:00am - 11:45am

Deep Dive into Fair Market Value – Mitigating Risks in HCP and Distributor Relationships

Examine FMV methodologies to prevent Anti-Kickback Statute violations and ensure transparent interactions
Navigate FMV complexities in distributor agreement through understanding price reporting implications and establishing compliant discount and service fee structures
Develop strategies to implement robust FMV oversight and monitor and audit FMV determinations, safeguarding against regulatory scrutiny and financial penalties

11:45am - 12:30pm

Clinical Research Compliance – Ensuring Ethical Clinical Investigator Interactions

Learn how to establish and maintain compliant investigator relationships and navigate fair market value (FMV) determinations, contract negotiation, and transparency in transfers of value
Delve into regulatory expectations for investigator interactions to understand and implement optimal guidelines for communication, data integrity, and conflict of interest management in clinical trials for both pre-approval and post-approval companies
Discuss how to implement effective oversight and monitoring of investigator activities and discuss best practices for documentation, audits, and addressing potential compliance risks throughout the trial lifecycle

Meena Datta - Partner, Sidley Austin LLP
Katy Van Pelt - Vice President, Head of Ethics & Compliance, Arcus Biosciences
Maria Robles - Senior Associate General Counsel and Chief Compliance and Privacy Officer, MannKind Corporation

12:30pm - 1:30pm

Networking Luncheon

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HCP Engagement & Communication

1:30pm - 2:15pm

Evolving Speaker Program Compliance – Responding to Enforcement Trends

How to establish robust criteria for speaker selection and attendee participation, ensuring transparency and mitigating conflict of interest risks
Assess the risks associated with speaker programs for legacy products and determine best practices for ongoing compliance
Analyze recent enforcement actions and apply lessons learned to strengthen your speaker program compliance strategy

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AI Utilization & Governance

2:15pm - 3:00pm

AI in Compliance – Real-World Use Cases and Risk Mitigation Strategies

Discuss case studies of how compliance programs can leverage AI to enhance monitoring activities
Learn how to develop AI governance policies and procedures to identify and mitigate risk for AI usage within your organization, including concerns with data privacy and AI-generated content

3:00pm - 3:05pm

Chair's Closing Remarks and Close of Conference

Day Two: Friday, September 5Friday, September 5, 2025